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Trulicity ® (dulaglutide)
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What is the Long-Term Safety Profile of Trulicity® (dulaglutide)?
Dulaglutide was evaluated up to 104 weeks in the double-blind AWARD-5 trial. Compared to sitagliptin, dulaglutide 1.5 mg and 0.75 mg were associated with more treatment-emergent adverse events.
Safety information on long-term treatment with dulaglutide
The AWARD-5 study was an adaptive, multicenter, randomized, 104-week, double-blind study that compared once-weekly dulaglutide 1.5 mg and dulaglutide 0.75 mg treatments with once-daily sitagliptin 100 mg and placebo in patients with T2DM inadequately controlled with metformin.1,2
Treatment with dulaglutide was associated with a significantly higher incidence of GI TEAEs than treatment with sitagliptin (p<.05).1,2
Nausea, diarrhea, and vomiting were the most commonly reported AEs with the incidence highest after 2 weeks of treatment and decreased at the following visits.2
Both dulaglutide 1.5 mg and dulaglutide 0.75 mg treatment doses reported more AEs than the sitagliptin treatment group due to greater incidence of GI AEs (Adverse Events From Baseline to 104 Weeks in Patients Treated With Dulaglutide 1.5 mg, Dulaglutide 0.75 mg, or Sitagliptin 100 mg in the AWARD-5 Study).2
A similar incidence of serious AEs was reported across treatment groups (Adverse Events From Baseline to 104 Weeks in Patients Treated With Dulaglutide 1.5 mg, Dulaglutide 0.75 mg, or Sitagliptin 100 mg in the AWARD-5 Study).2
Variablea |
DULA 1.5 mg |
DULA 0.75 mg |
SITA 100 mg |
Treatment-emergent AEs ≥1 |
259 (85) |
255 (84) |
242 (77) |
Treatment-emergent GI AEs in ≥5% of participants |
|||
Nausea |
53 (17)b |
44 (15)b |
21 (7) |
Vomiting |
41 (14)b |
25 (8)b |
11 (4) |
Diarrhea |
49 (16)b |
36 (12)b |
18 (6) |
Abdominal pain |
21 (7) |
13 (4) |
11 (4) |
Abdominal distention |
13 (4) |
15 (5) |
3 (1) |
Dyspepsia |
18 (6) |
19 (6) |
14 (4) |
Pancreatic enzymes, median (Q1,Q3) [U/L] |
|||
Lipase |
6 (-1,14) |
6 (-1,18) |
3 (-2,9) |
Total amylase |
6 (-1,15) |
7 (-1,17) |
3 (-3,12) |
p-Amylase |
4 (0,9) |
4 (0,11) |
2 (-1,7) |
Pancreatitis |
0 (0) |
0 (0) |
2 (0.6) |
Serious AEs |
36 (12) |
23 (8) |
32 (10) |
Infections and infestations |
7 (2) |
3 (1) |
5 (2) |
Cardiac disorders |
6 (2) |
2 (1) |
4 (1) |
Neoplasms |
5 (2) |
3 (1) |
5 (2) |
GI AEs |
4 (1) |
2 (1) |
4 (1) |
Renal/urinary disorders |
5 (2) |
2 (1) |
0 (0) |
Death |
1 (<1) |
0 (0) |
2 (1) |
Injection site reactions |
4 (1.3) |
3 (1.0) |
3 (1.0) |
Hypoglycemiac, mean (SD) |
|||
Total |
0.0 (0.2) |
0.0 (0.5) |
0.0 (0.3) |
Documented symptomatic |
0.0 (0.1) |
0.0 (0.5) |
0.0 (0.3) |
Discontinuation resulting from AEs |
63 (21) |
64 (21) |
65 (21) |
Vital signs, LSM (SE) |
|||
Systolic blood pressure, mm Hg |
-0.1 (0.8) |
1.3 (0.8) |
<0.1 (0.8) |
Diastolic blood pressure, mm Hg |
0.4 (0.5) |
1.4 (0.5)b |
-0.4 (0.5) |
Pulse rate, beats/min |
2.3 (0.5)d |
2.8 (0.5)d |
-0.8 (0.5) |
Abbreviations: AEs = adverse event; AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; DULA = dulaglutide; GI = gastrointestinal; LSM = least squares mean; Q1 = first quartile; Q3 = third quartile; SITA = sitagliptin; U/L = units per liter.
aData presented as n (%) unless otherwise indicated.
bp<.05 vs sitagliptin.
c<54 mg/dL cutoff, 1-year adjusted rate.
dp<.001 vs sitagliptin.
References
1Nauck M, Weinstock RS, Umpierrez GE, et al. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care. 2014;37(8):2149-2158. http://dx.doi.org/10.2337/dc13-2761
2Weinstock RS, Guerci B, Umpierrez G, et al. Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study. Diabetes Obes Metab. 2015;17(9):849-858. http://dx.doi.org/10.1111/dom.12479
3Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: 06 January 2021